EUCTR2006-002808-34-IT进行中(未招募)不适用
A phase II study of isolated lung perfusion with melphalan followed by pulmonary metastasectomy in patients with resectable pulmonary metastases of colorectal carcinoma, soft tissue sarcoma and osteosarcoma
未提供0 个研究点目标入组 100 人开始时间: 2013年11月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age of 18 years and older.
- •Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas
- •Patients with pulmonary metastases from colorectal carcinoma, sarcomas of soft tissue and osteosarcomas
- •?Cytologic/histologic proof or high clinical probability of pulmonary metastases of colorectal carcinoma, soft tissue sarcoma or osteosarcoma
- •?No other systemic metastases present than pulmonary metastases
- •?Primary site has been radically treated without signs of recurrence
- •?Patient is a candidate for pulmonary metastasectomy with no more than 10 pulmonary metastases documented on CT scan of the thorax. Metastases must be located primarily in the periphery of the lungs.
- •?No standard treatment options available, except pulmonary metastasectomy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Pregnancy/lactation
- •?Uncontrollable infectious disease
- •?Liver/renal insufficiency; serum creatinine more than 130 µmol/l and urine creatinine clearance less than 60 ml/min, ALAT and ASAT more than 3 times normal.
- •?Severe comorbidity
- •?Previous thoracotomy or pleuropulmonary diseases resulting in obliteration of the pleural space
研究者
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